A Multiple Component Mobile-aid Pain Reduction Intervention to Decrease Myofascial Pain

Summary

The goal of this clinical trial is to pilot test a newly developed multiple component mobile-aid pain reduction intervention (MCMAPRI) and the feasibility of implementing this intervention in adult patients with myofascial pain syndrome of the low back. The main questions it aims to answer are:

* What are the effects of the MCMAPRI intervention on reducing levels of myofascial pain in adult patients with myofascial pain syndrome of the low back?
* What is the feasibility for implementing the MCMAPRI intervention in adult patients with myofascial pain syndrome of the low back?

Participants will be randomly assigned to one of three groups: no treatment group, MCMAPRI intervention + sham osteopathic manipulation treatment, or MCMAPRI intervention +osteopathic manipulation treatment.

* Participants assigned to the no treatment group will only receive educational materials through email and a weekly phone call from the coordinator to reduce dropouts.
* Participants assigned to the multiple component mobile-aid pain reduction intervention+sham osteopathic manipulation treatment group will be asked to engage in posture training through a wearable device (i.e., UPRIGHT GO), a core muscle training and stretching exercise program, stress reduction through breath focus, and in strategies to improve their level of daily activity (i.e., wearing a Garmin device). This group will receive a sham osteopathic manipulation treatment by placing hands on the patient as if osteopathic manipulation treatment is being performed.
* Participants assigned to the MCMAPRI intervention+sham osteopathic manipulation treatment group will be asked to engage in posture training through a wearable device (i.e., UPRIGHT GO), a core muscle training and stretching exercise program, stress reduction through breath focus, and in strategies to improve their level of daily activity (i.e., wearing a Garmin device). This group will receive actual osteopathic manipulation treatment by putting pressure on certain muscles in the back and performing osteopathic manipulation treatment exercises on the patient.

Researchers will compare the no treatment group, multiple component mobile-aid pain reduction intervention+sham osteopathic manipulation treatment group, and multiple component mobile-aid pain reduction intervention+osteopathic manipulation treatment group to see if there are decreased levels of pain, increased physical activity, better posture, and reduced levels of stress.

Conditions

• Myofascial Pain Syndrome

Interventions

BEHAVIORAL

Multiple Component Mobile-Aid Pain Reduction Intervention

1.Posture training through the wearable device, UPRIGHT GO. The participant wears the device on their neck. The device provides biofeedback to poor posture with vibrations and tracks posture. 2. A daily core muscle training and stretching exercise program including trunk rotation, lumbar rotation, hip flexor stretch, side plank, glute bridge, suitcase carry, and palloff press. 3. Participants will practice stress reduction through breath focus which will help them to concentrate on deep breathing to help them ignore distracting thoughts and sensations. 4. Strategies to improve daily level of activity including wearing a Garmin device that tracks their daily physical activity and reminds them to walk and the use of the communication principle to assist participants in overcoming barriers to physical activity.

OTHER

Osteopathic Manipulation Treatment

Osteopathic Manipulation Treatment (OMT) will be conducted by putting pressure on certain muscles in the back and performing OMT exercises on the patient. The physician will treat participants with OMT twice during month 1 and once during month 2 and 3.

OTHER

Sham Osteopathic Manipulation

The sham osteopathic manipulation treatment (OMT) will be performed by the medical team. Hands will be placed on the patient as if the OMT is being performed. The physician will treat participants with sham OMT twice during month 1 and once during month 2 and 3.

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine

  collaborator OTHER

• Kailea Manning

  lead OTHER

Principal Investigators

• Pao-Feng Tsai, PhD · Auburn University

• Joseph Edison, DO · Edward Via College of Osteopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-31

Primary Completion

2023-09-30

Completion

2023-12-31

Countries

• United States

Study Locations